- Responsible for execution of Analytical Method Development (Assay, Dissolution, Related substances, content, UOD, PSD.), Analytical method feasibility activities of drug substance / drug product / excipients.

- Responsible for execution of activities related to Regulatory query and performing RLD analysis and COA generation.

- Responsible for preparation of assessment report, Method Development report, Method Equivalency report of drug product.

- Responsible for performing the qualification and calibration of analytical instruments like HPLC, IR and other standalone instruments (like water content, pH meter, Balances etc.,).

- Responsible for preparation of protocols / reports / standard operating procedures and Standard Testing Procedures.





- Responsible for following cGLP/cGMP compliance of the Analytical Laboratory, ensuring laboratory safety, valuable laboratory practices, Good Documentation practice in the lab and general cleanliness and Training & development activities.

- Monitoring and supporting all method transfer related activities from ARD to the CMO locations.

- Responsible for to execute authorized to sign (as prepared and checked by) for, Certificate of analysis, Calibration record, Specification and Standard test procedure, Method Validation / transfer/Reverse Engineering / protocols and reports, Method equivalency report.

M. Pharm with 4-6 years experience

📌 Research Associate (Kukatpally)
🏢 Difgen Pharmaceuticals
📍 Kukatpally